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Zanidip (LERCANIDIPINE)

Phase 3 active Small molecule Under review

Zanidip (generic name: LERCANIDIPINE) is a lercanidipine drug. It is currently in Phase 3 development for Hypertensive disorder.

Zanidip works by blocking calcium channels in blood vessel walls, causing them to relax and widen.

Zanidip, a small molecule, is used to treat conditions such as hypertension, essential hypertension, and chronic kidney diseases. It is often used in combination with other medications like hydrochlorothiazide and spironolactone.

Likelihood of approval
56.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Cardiovascular Phase 3 risk -2.0pp
    Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030 —
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameLERCANIDIPINE
Drug classlercanidipine
TargetVoltage-gated L-type calcium channel
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 3

Mechanism of action

Imagine your blood vessels as roads with tight traffic lights. Calcium channels are like the traffic lights that control how much blood can flow through the roads. When Zanidip blocks these channels, the traffic lights turn green, allowing more blood to flow and reducing blood pressure.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Zanidip

What is Zanidip?

Zanidip (LERCANIDIPINE) is a lercanidipine drug, indicated for Hypertensive disorder.

How does Zanidip work?

Zanidip works by blocking calcium channels in blood vessel walls, causing them to relax and widen.

What is Zanidip used for?

Zanidip is indicated for Hypertensive disorder.

What is the generic name of Zanidip?

LERCANIDIPINE is the generic (nonproprietary) name of Zanidip.

What drug class is Zanidip in?

Zanidip belongs to the lercanidipine class. See all lercanidipine drugs at /class/lercanidipine.

What development phase is Zanidip in?

Zanidip is in Phase 3.

What are the side effects of Zanidip?

Common side effects of Zanidip include Acute kidney injury, Hyponatraemia, General physical health deterioration, Hyperkalaemia, Lactic acidosis, Pemphigoid.

What does Zanidip target?

Zanidip targets Voltage-gated L-type calcium channel and is a lercanidipine.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing